A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer
Trial Parameters
Brief Summary
This Phase II study is a clinical trial to evaluate the efficacy and safety of BL-B01D1 + pembrolizumab dual therapy with or without bevacizumab (BL-B01D1 + pembrolizumab ± bevacizumab) in patients with recurrent or metastatic cervical cancer and endometrial cancer.
Eligibility Criteria
Inclusion Criteria: 1. The subject voluntarily participates in this study and signs the informed consent form; 2. Age ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG performance status score of 0-1; 5. Patients with recurrent or metastatic cervical cancer or endometrial cancer confirmed by histopathology and/or cytology; 6. Archived tumor tissue samples from the primary or metastatic lesions within the past 3 years must be provided for PD-L1 and other testing; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Organ function levels must meet the requirements; 9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum or urine pregnancy test must be negative. Patients must not be lactating. All enrolled patients must use adequate barrier contraception